PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i VijećaNovi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina. EU je... Latest updates News announcement14 rujan 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)News announcement14 rujan 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)News announcement10 kolovoz 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodiesNews announcement5 kolovoz 2022Call for EU reference laboratories sent to Member StatesPrikaži sve Highlights News announcement5 kolovoz 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 lipanj 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 07svi2021 Partnerski sastanci Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…
DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i Vijeća
Novi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina. EU je...
News announcement14 rujan 2022MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)
News announcement14 rujan 2022MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)
News announcement10 kolovoz 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
